Unasyn

Unasyn

sultamicillin

ampicillin + sulbactam

Manufacturer:

Pfizer

Distributor:

IQVIA
Concise Prescribing Info
Contents
Sultamicillin (ampicillin & sulbactam). Per 750 mg tab Ampicillin 440 mg, sulbactam 294 mg. Per 1.5 g inj Ampicillin Na 1,000 mg, sulbactam Na 500 mg. Per 3 g inj Ampicillin Na 2,000 mg, sulbactam Na 1,000 mg
Indications/Uses
Infections caused by susceptible micro-organisms. Upper & lower resp tract infections including sinusitis, otitis media; bacterial pneumonia; UTI & pyelonephritis; skin & soft tissue & gonococcal infections. Tab: Tonsillitis; bronchitis. Patients requiring sulbactam/ampicillin therapy following initial IM/IV treatment. IM/IV: Epiglottis; intra-abdominal infections including peritonitis, cholecystitis, endometritis & pelvic cellulitis; bacterial septicemia; bone & joint infections. Reduction of incidence of post-op wound infections in patients undergoing abdominal or pelvic surgery, in which peritoneal contamination may be present. Prophylaxis to reduce post-op sepsis in termination of pregnancy or cesarean section.
Dosage/Direction for Use
Tab Adult & childn Duration of treatment: 5-14 days. Adult (including elderly) 750 mg bid. Uncomplicated gonorrhea 2.25 g (as three 750 mg tab) given as single oral dose in concomitant use w/ probenecid 1 g. Infection caused by hemolytic Strep At least 10 days of treatment. Childn weighing ≥30 kg Usual adult dose, <30 kg 25-50 mg/kg daily in 2 divided doses. IM/IV Administer as bolus inj over min of 3 min or as IV infusion over 15-30 min. May also be administered by deep IM inj. Adult 1.5-12 g daily in divided dose every 6-8 hr. Max daily dose of sulbactam: 4 g. Less severe infection Administer every 12 hr. Max daily dose: Mild infection 1.5-3 g, moderate infection Up to 6 g, severe infection Up to 12 g. Duration of treatment: 5-14 days. Surgical prophylaxis 1.5-3 g at induction of anesth, may be repeated every 6-8 hr. Uncomplicated gonorrhea 1.5 g as single dose in concomitant use w/ probenecid 1 g. Infections Childn, infant & neonate 150 mg/kg daily every 6-8 hr. Neonate during 1st wk of life (especially pre-term) 75 mg/kg daily every 12 hr.
Administration
May be taken with or without food.
Contraindications
History of allergic reaction to any penicillins.
Special Precautions
Discontinue treatment if allergic reactions; severe skin reactions (eg, TEN, SJS, exfoliative dermatitis, erythema multiforme & acute generalized exanthematous pustulosis; superinfection occur. Serious & occasionally fatal hypersensitivity (anaphylactic) reactions; history of hypersensitivity reactions to penicillins, cephalosphorins & other allergens. Not to be used in infectious mononucleosis. Constantly observe for signs of overgrowth of non-susceptible organisms including fungi. Consider Clostridium difficile associated diarrhea (CDAD) in patients w/ diarrhea following antibiotic use. Periodically check for organ system dysfunction during prolonged therapy, including renal, hepatic & hematopoietic systems. Drug induced liver injury eg, cholestatic hepatitis & jaundice. Severe renal impairment (CrCl ≤30 mL/min). Pregnancy & lactation. Neonates w/ undeveloped renal function. Tab: Galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption.
Adverse Reactions
Anaemia, thrombocytopenia, eosinophilia; diarrhoea; hyperbilirubinaemia; increased ALT/AST. TEN, SJS, erythema multiforme. Tab: Pseudomembranous colitis, Candida infection; anaphylactic shock & reaction, Kounis syndrome, hypersensitivity; dizziness, somnolence, sedation, headache; dyspnea; enterocolitis, melena, vomiting, abdominal pain, dyspepsia, nausea, stomatitis, dysgeusia, tongue discolouration; jaundice, abnormal hepatic function; angioedema, urticaria, dermatitis, rash, pruritus; arthralgia; fatigue, malaise; abnormal platelet aggregation. IM/IV: Phlebitis; inj site pain.
Drug Interactions
Increased incidence of rashes w/ allopurinol. May produce additive effects w/ anticoagulants. May interfere w/ bactericidal effects w/ bacteriostatics (chloramphenicol, erythromycin, sulfonamides & tetracyclines). Reduced effectiveness of estrogen-containing OCs. Decreased clearance & increased toxicity of MTX. Decreased renal tubular secretion w/ probenecid. False +ve glycosuria in pregnant women w/ Benedict & Fehling reagent, & Clinitest. IM/IV: Substantial mutual inactivation w/ aminoglycosides.
MIMS Class
Penicillins
ATC Classification
J01CR01 - ampicillin and beta-lactamase inhibitor ; Belongs to the class of penicillin combinations, including beta-lactamase inhibitors. Used in the systemic treatment of infections.
J01CR04 - sultamicillin ; Belongs to the class of penicillin combinations, including beta-lactamase inhibitors. Used in the systemic treatment of infections.
FC tab: D; Inj: S
Presentation/Packing
Form
Unasyn FC tab 750 mg
Packing/Price
3 × 4's
Form
Unasyn powd for inj 1.5 g
Packing/Price
1's
Form
Unasyn powd for inj 3 g
Packing/Price
1's
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